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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device folders and injectors, intraocular lens (iol)
Product CodeMSS
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AST PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAUSCH & LOMB, INC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON SURGICAL VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICEL AG
  SUBSTANTIALLY EQUIVALENT 1
RXSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 271 271
2020 362 362
2021 289 289
2022 490 490
2023 330 330
2024 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 389 389
Device Contamination with Chemical or Other Material 386 386
Adverse Event Without Identified Device or Use Problem 225 225
Crack 195 195
Scratched Material 138 138
Material Split, Cut or Torn 136 136
Break 92 92
Contamination /Decontamination Problem 73 73
Defective Device 57 57
Failure to Eject 45 45
Physical Resistance/Sticking 34 34
Contamination 30 30
Material Fragmentation 22 22
No Apparent Adverse Event 21 21
Use of Device Problem 18 18
Appropriate Term/Code Not Available 17 17
Insufficient Information 16 16
Material Twisted/Bent 16 16
Failure to Advance 16 16
Defective Component 15 15
Particulates 15 15
Fracture 13 13
Mechanical Problem 10 10
Material Separation 10 10
Activation, Positioning or Separation Problem 9 9
Difficult to Remove 8 8
Burst Container or Vessel 8 8
Difficult to Advance 7 7
Device Handling Problem 7 7
Inaccurate Delivery 6 6
Material Rupture 5 5
Unintended Ejection 5 5
Ejection Problem 5 5
Mechanical Jam 5 5
Entrapment of Device 4 4
Difficult to Insert 3 3
Off-Label Use 3 3
Material Deformation 3 3
Deformation Due to Compressive Stress 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 2 2
Material Protrusion/Extrusion 2 2
Therapeutic or Diagnostic Output Failure 2 2
Noise, Audible 2 2
Fitting Problem 2 2
Product Quality Problem 2 2
Material Too Rigid or Stiff 1 1
Inadequacy of Device Shape and/or Size 1 1
Stretched 1 1
Unstable 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Failure to Deliver 1 1
Material Puncture/Hole 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Difficult or Delayed Positioning 1 1
Complete Blockage 1 1
Premature Discharge of Battery 1 1
Biofilm coating in Device 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
No Pressure 1 1
Operating System Becomes Nonfunctional 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contaminated During Manufacture or Shipping 1 1
Contamination of Device Ingredient or Reagent 1 1
Expiration Date Error 1 1
Malposition of Device 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 682 682
Insufficient Information 517 517
No Known Impact Or Consequence To Patient 286 286
No Consequences Or Impact To Patient 106 106
Capsular Bag Tear 60 60
No Code Available 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Eye Injury 31 31
Foreign Body In Patient 30 30
Vitrectomy 26 26
Visual Impairment 17 17
Visual Disturbances 10 10
Corneal Edema 9 9
Vitreous Loss 7 7
Failure of Implant 7 7
Foreign Body Sensation in Eye 6 6
Blurred Vision 6 6
No Information 5 5
Inflammation 5 5
No Patient Involvement 5 5
Corneal Abrasion 4 4
Device Embedded In Tissue or Plaque 4 4
Eye Pain 4 4
Unspecified Eye / Vision Problem 3 3
Edema 3 3
Hemorrhage/Bleeding 3 3
Endophthalmitis 3 3
Uveitis 2 2
Iritis 2 2
Vitreous Floaters 2 2
Halo 2 2
Toxic Anterior Segment Syndrome (TASS) 2 2
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1
Unspecified Tissue Injury 1 1
Discomfort 1 1
Injury 1 1
Intraocular Pressure Increased 1 1
Pain 1 1
Increased Sensitivity 1 1
High Blood Pressure/ Hypertension 1 1
Hyphema 1 1
Macular Edema 1 1
Corneal Decompensation 1 1
Corneal Perforation 1 1
Corneal Scar 1 1
Corneal Touch 1 1
Failure to Anastomose 1 1
Wound Dehiscence 1 1
Abrasion 1 1
Bacterial Infection 1 1
Conjunctivitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Rayner Intraocular Lenses Limited II Apr-21-2020
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